2021-2024年国家致病菌识别网网络实验室肠杆菌科细菌药敏试验室间质量评价结果分析

Inter quality evaluation of antimicrobial susceptibility testing for Enterobacteriaceae in laboratories in China Pathogen Identification Network, 2021−2024

  • 摘要:
    目的 分析国家致病菌识别网2021—2024年网络实验室肠杆菌科细菌药敏试验室间质量评价结果,评价网络实验室检测质量,为促进国家致病菌识别网监测质量提升提供数据支持。
    方法 2021—2024年国家中心实验室向省级中心实验室和地市级网络实验室发放6株(肠杆菌科)考核菌株,各级网络实验室进行17种抗生素的药敏试验。 实验结果通过国家致病菌识别网信息系统上报。 药敏试验结果判读以监测技术手册为准。 使用R 4.3.2软件对不同地区实验室的检测结果进行分析。
    结果 2021—2024年6株菌的最小抑菌浓度值测试准确率为90.49%,敏感/中介/耐药判定准确率为97.81%。 偏离值中89.36%分布在与参考值相差1个梯度中。 除参考值外,阿米卡星药敏试验结果的偏离值均分布在高于参考值1个梯度范围中。 阿奇霉素药敏试验结果梯度范围最大,与参考值相差低于5个梯度至高于5个梯度。 QC2022_01、QC 2024_02、所有6株菌的药敏试验结果准确率在不同地区实验室间的差异具有统计学意义(P<0.05)。 华北地区网络实验室6株菌的药敏结果的准确率最高。
    结论 为提高各级网络实验室药敏试验结果准确率,应进一步做好实验室质量控制和标准化方法的推广应用。 不同地区实验室药敏试验的能力存在差异,应加强对东北、西北、西南地区的网络实验室细菌药敏试验的实验培训和技术指导。

     

    Abstract:
    Objective To evaluate the quality of antimicrobial susceptibility testing (AST) for Enterobacteriaceae in laboratories in China Pathogen Identification Network (China PIN) from 2021 to 2024 and provide data support for the improvement of of surveillance quality.
    Methods The national central laboratory distributed 6 test strains (Enterobacteriaceae) to provincial central laboratories and prefectural (municipal) laboratories in the network from 2021 to 2024. Each network laboratory conducted AST to 17 types of antibiotics. The testing results were reported through China PIN information system. The AST was conducted based on the surveillance technical manual. Software R 4.3.2 was used to analyze the results from laboratories in different regions in China.
    Results From 2021 to 2024, the accuracy rate of minimum inhibitory concentration test of the six Enterobacteriaceae species was 90.49%, and the accuracy rate of sensitivity/intermediate/resistance was 97.81%. Of the deviation values, 89.36% were distributed within the 1 gradient of reference value. In addition to the reference value, the results of amikacin susceptibility test were all distributed above 1 gradient of reference value. Azithromycin susceptibility test results showed the widest gradient range from <5 gradients to >5 gradients of the reference value. Statistical analysis revealed significant regional differences (P<0.05) in AST accuracy for QC2022_01, QC2024_02, and six Enterobacteriaceae species. The accuracy rate of AST for 6 species in the network laboratories of northern China was highest.
    Conclusion To improve the accuracy of AST in the laboratory network, it is necessary to strengthen the quality control and promote standardized test methods. Differences existed in the AST performance among the laboratories in different regions, it is important to improve training and technical guidance in network laboratories in northeastern, northwestern and southwestern China.

     

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